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FDA 510(k)

Altaviz Needle Kit

K-Number: K222681 · 2022-12-05

ApplicantAltaviz, LLC
Decision Date2022-12-05
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Altaviz Needle Kit is the device name listed in this FDA 510(k) record. The listed applicant is Altaviz, LLC. It received FDA 510(k) clearance on 2022-12-05 under 510(k) number K222681. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altaviz Needle Kit?

Altaviz Needle Kit is a medical device that received FDA 510(k) clearance on 2022-12-05. The listed applicant is Altaviz, LLC. The 510(k) number is K222681.

When did Altaviz Needle Kit receive FDA 510(k) clearance?

Altaviz Needle Kit received FDA 510(k) clearance on 2022-12-05, under 510(k) number K222681.

Who is the listed applicant for Altaviz Needle Kit?

The FDA 510(k) record lists Altaviz, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Altaviz Needle Kit?

The FDA product code for Altaviz Needle Kit is FMI.

Other records listing Altaviz, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243322Altaviz Intravitreal SyringeK231261Altaviz Needle Kit II

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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